Z-0231-2024Class II

BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid

Name: Z-0231-2024 BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid
Creator: Breg Inc
Published: 2023-09-13
License: https://open.fda.gov/license/

Breg Inc / initiated 2023-09-13 / Open, Classified / root cause: manufacturing process

FDA source

Breg Inc began a recall of BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid on 2023-09-13. FDA classified it as Class II and gives the reason as "Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0231-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-13
Posted: 2023-11-03
Recalling firm: Breg Inc
Product: BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Product code: ITJ Walker, Mechanical
Reason for recall: Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 09/13/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customer informing them that folding walkers distributed between June 2023 to August 2023 did not meet product specifications for wheel alignment. Products exhibit: -Misalignment of wheels may result in immobility of walker -Misalignment of wheels may result in obstruction of glide/roll Customers are instructed to: -Immediately examine their inventory and quarantine products subject to this recall -For devices separated from labeling, visual examination of devices may be required. The misalignment looks like the wheels are not parallel to each other. -Segregate product with misaligned wheels and return to Breg via Return Material Authorization (RMA or Return Inventory (RI) process. -Review and fill out the response form and return to Breg. For questions, email to [email protected]
Quantity in commerce: 11,193 units
Distribution: U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A
Product codes and lots: Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0231-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0231-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)